CLASS II Drug recall · Reported 6 Nov 2019 · FDA Enforcement Report
Children's Ibuprofen Oral Suspension USP, 100 mg recalled
Taro Pharmaceuticals U is recalling Children's Ibuprofen Oral Suspension USP, 100 mg per, Berry Flavor, Dye-Free, Alcohol Free, distributed nationwide in the US. The recall was initiated on 27 Sep 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0300-2020
- FDA event ID
- 83887
- Recalling firm
- Taro Pharmaceuticals U, Hawthorne, NY
- Brand
- Ibuprofen
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Sep 2019
- FDA classified
- 5 Nov 2019
- Reported
- 6 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 27 Sep 2019 | Recall initiated by company | |
| 5 Nov 2019 | Classified by FDA | +39 days |
| 6 Nov 2019 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Product as listed by the FDA
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Which lots are affected?
Lot #: E875131667, E875231667, Exp 4/20; J871033189, J871133189, Exp 9/20; A972934375, A973034375, Exp 12/20
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 83887This product is part of a recall event; the main page for the event is Ibuprofen Oral Suspension USP, 100 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ibuprofen Oral Suspension USP, 100 mg recalledIbuprofen | Taro Pharmaceuticals U | Particulate Matter | Nationwide | |
| CLASS II | Children's Ibuprofen Oral Suspension USP, 100 mg recalledIbuprofen | Taro Pharmaceuticals U | Particulate Matter | Nationwide | |
| CLASS II | Ibuprofen Oral Suspension USP, 100 mg recalledIbuprofen | Taro Pharmaceuticals U | Particulate Matter | Nationwide | |
| CLASS II | Children's Ibuprofen Oral Suspension USP, 100 mg recalled | Taro Pharmaceuticals U | Particulate Matter | Nationwide |
More recalls from Taro Pharmaceuticals U
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hydrocortisone 1% & Acetic Acid 2% Otic Solution recalled | Taro Pharmaceuticals U | Potency & Assay | NY |
| Drug | CLASS III | Clotrimazole and Betamethasone Dipropionate Cream recalledClotrimazole And Betamethasone Dipropionate | Taro Pharmaceuticals U | Potency & Assay | NY |
| Drug | CLASS I | Clobetasol Propionate Ointment USP, 0.05% tubes recalledClobetasol Propionate | Taro Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Nortriptyline HCl Capsules, USP equivalent to 10mg base recalledNortriptyline Hydrochloride | Taro Pharmaceuticals U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | H-e-b - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal recalledHEB | Taro Pharmaceuticals U | Potency & Assay | Nationwide |
Other Ibuprofen recalls
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Children's Ibuprofen Oral Suspension, USP, 100 mg recalledIbuprofen | Strides Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | IBU (ibuprofen) recalled by Dr. Reddy's LaboratoriesIBU | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled | Direct Rx | Potency & Assay | Nationwide |
| Drug | CLASS II | IBU Ibuprofen Tablets, USP, 600 mg recalled by Dr. Reddy's LaboratoriesIBU | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | IBU Ibuprofen Tablets, USP, 400 mg recalled by Dr. Reddy's LaboratoriesIBU | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |